Light-emitting diode and massage device for delivering focused light for vaginal rejuvenation

ABSTRACT

A rejuvenation and massage device is provided for treating mucosa tissue, such as vaginal tissue, affected by Vaginal Relaxation Syndrome (VRS) or other conditions, through vibration, thermal loading, and light emittance for a duration of time. In one embodiment, the device is an insertable device that includes Low-Level Laser Light (LLLT) therapy to treat the vaginal tissue. The light emittance by one or more light emitters is in a range sufficient to provide therapeutic effects through light radiation. To enhance the therapeutic effects of light radiation provided by the device, the device is configured to provide increased energy density into target tissue of vaginal muscles though a light configuration component (e.g., a focusing component, such as a concave lens assembly, a convex assembly, a pre-lensed light emitter or other focusing optical mechanism) associated with the light emitter that concentrates the light emitted from the light emitter.

BACKGROUND

This invention relates generally to vaginally-insertable devices, morespecifically to vaginal rejuvenation insertable devices, which provideincreased energy density into target tissue of vaginal muscles, andenhance the therapeutic effects of light radiation provided by thedevices.

After child birth or with aging, women can experience weakening orrelaxing of their vaginal muscles. This relaxation of vaginal muscle isknown as Vaginal Relaxation Syndrome (VRS) or vaginal wall distensionand it negatively impacts sexual intercourse, can cause intimacy andself-esteem problems, and can lead to urinary incontinence. Conventionalsolutions for tightening relaxed vaginal muscle include kegel exercisesand vaginal creams, but these are generally ineffective. Costly andinvasive procedures for vaginal rejuvenation (e.g., vaginoplasty orlaser vaginal rejuvenation) are another option, but these also fail toprovide a safe, comfortable, affordable option for vaginal rejuvenation.Clinical treatment devices for insertion into the vagina to providetreatment are also available. However, the ability of these conventionaldevices to actually treat VRS appears to be limited. Furthermore, thesedevices are for treatment in a clinical setting, and are not designed acompact device for consumer or home use, nor are they designed to beenjoyable for the woman to use, making it less likely that regulartreatments will occur and decreasing effectiveness of the devices.

SUMMARY

A rejuvenation and massage device for the vaginal lumen includes aninsertable device that repairs mucosa tissue, such as vaginal tissue,after VRS for example, through vibration, thermal loading, and lightemittance for a duration of time. In one embodiment, the device includesLow-Level Laser Light (LLLT) therapy to treat the vaginal tissue. Thelight emittance by one or more light emitters is in a range sufficientto prevent apoptosis and cell death, stimulate fibroblast proliferation,migration and collagen synthesis, modulate inflammatory and anti-oxidantresponses, and/or simulate angiogenesis and tissue repair in the vaginaltissue.

To enhance the therapeutic effects of light radiation provided by thedevice, the device is configured to provide increased energy densityinto target tissue of vaginal muscles though a light configurationcomponent. The light configuration component is associated with one ormore light emitters of the device and is configured to increase theenergy density deposited into the target tissue of vaginal muscles of auser of the device. For example, the light configuration component isconfigured to concentrate the light emitted from a light emitter via afocusing component, e.g., a concave lens assembly, a convex assembly, apre-lensed light emitter or other focusing optical mechanism, on aboveor top of the light emitter. The focusing component is configured torefract the light emitted from the light emitter, which increases thepower density being delivered to the vaginal tissue contacted by thedevice without using disproportionately more battery power, withoutincreasing the heat output from the light emitters, and without riskingdamage to the device or to the users of the device.

To repair mucosa tissue, such as vaginal tissue, through vibration, thedevice applies a controlled amount of heat to the subdermal connectivetissues surrounding the vaginal mucosa, in particular to the vaginalmucosa of post-parous women who have experienced significant loss ofvaginal tone and tissue tension due to tissue stretching, elastaseenzyme production, hypoxia, and mechanical stress during birth. Themechanism of action is primarily collagenous remodeling withinconnective tissue surrounding the vaginal canal in a sequential processstarting with collagen melting and ending with inflammatory and fibroticresponses generating significant tightening of the vaginal lumen. Insome embodiments, the heat is applied at a temperature range sufficientto induce neocollagenesis, neofibrogenesis, or neoelastogenesis.

The device also vibrates to provide massage to the tissue, and thisvibration may also increase the healing response in the vaginal tissue.The massage induces a pleasure response in the user, making the deviceenjoyable to use and encouraging longer use of the device. Since thedevice is used for a greater length of time, a controlled application ofheat at a lower level can occur for a greater length of time to moreeffectively induce collagen melting. With the application of vibration,it is possible to enhance the processes of neoelastogenesis andneocollagenesis, thereby providing more effective repair and tighteningto the vaginal tissue. Thus, the vibration may be applied at a rangethat provides a pleasure response in the user. The vibration may also beapplied at a range sufficient to enhance myofibril generation andneocollagenesis while inducing a pleasure response.

The device can be designed to be a convenient at-home use device thatcan be manipulated by untrained users. In one embodiment, the device isa handheld device and most or all of the components are integratedwithin the handheld device. The device can have a variety of settingsthat can be controlled by the user or automatically by the device. Thedevice can also be designed to treat localized areas of intravaginaltissue rather than the entire length of the vaginal lumen, therebyincreasing the rate of healing from adjacent untreated tissue sites. Thedevice can also be used with certain customized lubricants.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B are graphs illustrating data associated with skin repair, inaccordance with an embodiment.

FIGS. 1C-1E are examples of a rejuvenation and massage device, inaccordance with an embodiment.

FIG. 2 is a block diagram of components in a rejuvenation and massagedevice, including a light configuration component for enhancing thetherapeutic effects of light radiation provided by the device, inaccordance with an embodiment.

FIG. 3 is a block diagram of an inducement environment for inducingneocollagenesis, neoelastogenesis, and neofibrogenesis by therejuvenation and massage device illustrated in FIG. 2, in accordancewith an embodiment.

FIG. 4 is a flowchart of a method for inducing neocollagenesis,neoelastogenesis, and neofibrogenesis, in accordance with an embodiment.

FIG. 5 is a flowchart of a method for vaginal rejuvenation performed bya user of an embodiment of the device, such as in FIGS. 1C-1E, inaccordance with an embodiment.

FIG. 6 is a flowchart of a method for an overall physiological processresulting from use of an embodiment of the device, such as in FIGS.1C-1E, in accordance with an embodiment.

FIG. 7 shows an example of a rejunvenation and massage device providingincreased energy density into target tissue of vaginal muscles through alight configuration component of the device, in accordance with anembodiment.

FIG. 8A shows a light emitting component having a light configurationcomponent configured to use a lens assembly in a concave configurationfor each light emitter of the device, in accordance with an embodiment.

FIG. 8B shows an example of positioning a lens assembly in a concaveconfiguration for each light emitter of the device on the outsidesurface of a transparent treatment window of the device, in accordancewith an embodiment.

FIG. 8C shows a light emitting component having a light configurationcomponent configured to use a lens assembly in a convex configurationfor each light emitter of the device, in accordance with an embodiment.

FIG. 8D shows an example of positioning a lens assembly in a convexconfiguration for each light emitter of the device on the outsidesurface of a transparent treatment window of the device, in accordancewith an embodiment.

FIG. 8E shows an embodiment of a light configuration component in apre-lensed configuration, in accordance with an embodiment.

FIG. 9 shows examples of various views of a rejuvenation and massagedevice with enhanced light configuration, in accordance with anembodiment.

The figures depict various embodiments of the present invention forpurposes of illustration only. One skilled in the art will readilyrecognize from the following discussion that alternative embodiments ofthe structures and methods illustrated herein may be employed withoutdeparting from the principles of the invention described herein.

DETAILED DESCRIPTION

(a) Overview

Effects of Childbirth on Vaginal Walls

After child birth or with aging, women can experience the weakening orrelaxing of their vaginal muscles. For example, childbirth can causeplastic vaginal wall distension, also known as Vaginal RelaxationSyndrome (VRS). Peer-reviewed literature reveals that childbirth isassociated with a four- to seven-fold increase (1) in several pelvicfloor disorders including plastic vaginal distension, urinary and fecalincontinence, and pelvic organ prolapse. Literature suggests thatchildbirth causes direct muscular trauma or denervation injury of thestriated muscles of the pelvic floor (termed the levator ani) andthereby leads to failure of muscular support of pelvic organs. Thesedisorders affect one-third of adult women in the United States,impacting their quality of life (2, 3, 4, 5). One study of 149,554 adultwomen reported an 11 percent risk of undergoing a single operation forpelvic floor disorders or incontinence by age 80 and found that 29percent of these women required multiple surgeries (6).

Vaginal wall distension has been shown to result in increased expressionof the matrix metalloproteases MMP-2 and MMP-9, elastase enzymesexpressed predominantly in connective tissue and bone marrow cells (7).The elastase enzymes are responsible for destruction of elastin, anotherimportant protein such as collagen in connective tissue for establishingthe spring-like characteristics of connective tissue. Elastin damagereduces the ability of stretched connective tissue to reconform to theoriginal shape after stretching. In experiments carried out in mice, amicro-balloon is used to stretch the vaginal walls and numerousfragmented and disrupted elastin fibers were seen upon histologicalexamination (7). The upregulation of MMP-2 and -9 production afterdistension was pronounced as seen in Graph 1(a) and Graph 1(b),respectively, as shown in FIG. 1A.

In addition to the elastase effects, prolonged tissue stretching,hypoxia, and mechanical stress on the vaginal mucosal walls due tochildbirth contribute to plastic distension of the organ. Takentogether, the results indicate that vaginal wall distention inducesincreased protease activity and that elastic fiber synthesis is crucialfor recovery of the vaginal wall from distention-induced injury.

Reconformation of Collagen and Elastin Fibers

Vaginal muscle tissue structures, the vaginal mucosal walls, and thevaginal muscle tissue, like other tissue in the human body, include anextracellular matrix (ECM) of protein fibers and fibroblast cells withinthe ECM. To tighten the vaginal muscle tissue, the ECM of protein fibersor, more specifically, the protein fibers themselves can be tightened.The ECM includes fibers of multiple proteins, including collagen, aprimary structural protein such as elastin. The collagen protein has atriple helix structure with individual chains held together by hydrogenbonds and provides an elastic, resilient property to tissue due to theindividual chains aggregated together, which form fibrils withspring-like tensile properties.

One method of tightening the ECM includes tightening the collagen fibersby denaturing the fibers. Collagen fibers, as well as fibers of otherproteins denature and consequently tighten depending on the maximumtemperature to which they are exposed. At body temperature, the collagenfibrils form random coils (8). If exposed at temperatures only slightlyelevated over normal body temperature, the random coil configuration ofcollagen changes into a more linear configuration through a processcalled “melting.” This process is time dependent, and is governed by theArrhenius equation:k=Ae ^(−E) ^(a) /RT,where k is the rate constant, A the frequency of collisions betweenreacting molecules, E_(a) the activation energy, R the gas constant andT the absolute temperature (10). Collagen denaturation, according to theArrhenius equation, depends on temperature as well as time, as shown incollagen melting temperature data from live tissues in Graph 2 shown inFIG. 1A.

As seen, collagen can melt (denature) at a relatively low temperaturewhen exposed for 5 minutes or longer to a thermal load. Melting canoccur at or even below core body temperature. The low meltingtemperature allows collagen molecules to melt and refold locally,providing elasticity and strength in the connective tissue fibers. Thelow temperature threshold also permits collagen renaturation (refolding)to occur. At higher temperatures, the collagen protein transitionsthrough a significant configuration change where the fibers contract ortighten, in some cases dramatically, and the reconfiguration ordenaturation (e.g., shown in a mean change in tissue length of seventreatment groups during testing) is irreversible as seen in Graph 3shown in FIG. 1A.

A collagen fiber can contract to about 40% of the original length of thefiber, and then no further changes are possible despite increases intemperature. Collagen contraction initiates at approximately 60° C. andreaches denaturation by 80° C. as seen in subjective histologic scoresfor collagen structure of the seven treatment groups (mean+/−SD) inGraph 4 shown in FIG. 1A. The bars in Graph 4 with differing letters aresignificantly different from each other (P<0.05).

The human's perception of thermally-induced pain begins at 40° C. (104°F.), well below the required temperature for significant collagenshortening. Topical cooling can be an approach to this problem becausetopical anesthetic agents do not appear to increase the patient'stolerance of heat (11).

Once thermally-induced denaturation of the collagen protein andtightening of the ECM has occurred, neoelastogenesis and neocollagenesisoccur within a month after the denaturation (12). Neoelastogenesis andneocollagenesis are processes that include remodeling of the ECM as wellas integrating new protein fibers, elastin and collagen respectively, inthe existing ECM. According to research, these processes initiate sevendays after denaturation, a typical timeframe for proliferation offibroblast cells. The fibroblast cells secrete collagen, assist in theconstruction of new matrices with the secreted collagen, and effecttissue repair (9). Thermally-induced denaturation will cause contractionof protein fibers and improve tissue tone and connective tissue tension.

Effects of Vibration on Tissue

Research also shows that vibration has an effect on various human celltypes (13, 14, 15, 16, 17) including fibroblasts, participants in theremodeling of the ECM. In vivo, there are two ECM glycoproteins,tenascin and collagen XII, specifically expressed in places wheremechanical strain is high. Tenascin appears around healing wounds, andis part of the control response involving fibronectin, an importantprotein involved in collagen binding. Fibroblast cells attached to astrained collagen matrix produce more of the two ECM glycoproteins thanfibroblast cells attached to a relaxed collagen matrix (13). Thus, wholebody vibration training is widely used in rehabilitation and sportsactivities to improve muscle strength, balance, and flexibility byutilizing the effect of vibration (18).

Various other studies show that vibration affects the production ofproteoglycans, primary proteins found in connective tissue, in3-dimensional cultured chondrocyte cells in cartilage (19) and enhancesformation of a muscle fibril progenitor myotube in female athletespreconditioned with low-magnitude vibration with maximum expression oftype I collagen occurring when frequencies of 8-10 Hz were used (16).Low-magnitude vibration has been shown to enhance myotube or musclefibril formation, with maximum expression of type I collagen occurringwhen frequencies of 8-10 Hz were used (20).

The effects of vibration on the gene expression of type I collagen havebeen shown to be profound (20) as seen in the effects of vibration oncollagen gene upregulation in Graph 5 shown in FIG. 1B. A factor of 3-4×enhancement in gene expression of type I collagen protein and β-actinprotein was found. As seen, the largest effects were found at 5 Hz. Afactor of greater than 7× was found for gene expression of myoD, amaster regulator protein in the early and terminal differential stagesof myogenesis, at 10 Hz (20) as seen the effects of vibration on myoDgene upregulation in Graph 6 as shown in FIG. 1B. These gene expressionenhancements were mirrored at the cellular level, with myotube number,length, area and fusion index or rate of new cell production allincreasing by similar orders of magnitude under the effects of vibration(20) as seen in the effects of vibration on myotube number in Graph 7,as shown in FIG. 1B.

In addition to the effects that vibration has on fibroblasts, thevibration provides the benefit of massaging the vaginal tissue andproviding a pleasure response in the user. This additional benefit meansthat the device may be used more frequently and for a longer period orduration of time, making it easier to have regular, more effectivetissue treatments. Collagen is known to melt at around 60° C. to 80° C.,though temperatures at 40° C. and above can become uncomfortable to theuser. Since a vibrating device is designed to induce pleasure duringuse, it may be used for a longer period of time. If the time duringwhich heat is applied is extended, it is possible to cause collagenmelting at lower temperatures, thus ensuring that the temperatures canremain comfortably within the zone that does not provide pain ordiscomfort to the user. So, the vibration not only has positive effectson the healing of tissue, but also provides the benefit of making thedevice enjoyable to use and potentially extending duration of use,allowing for usage of lower temperatures to effect collagen melting,renaturation and subsequent de novo formation.

Effects of Low-Level Laser Light on Tissue

In addition to vibration, research shows that low-level laser light(LLLT) also affects fibroblasts by stimulating fibroblast proliferation,migration and collagen synthesis. Laser light in the deep red portion ofthe spectrum including some near-infrared portions also preventsapoptosis and cell death, modulates inflammatory and anti-oxidantresponses, and stimulates angiogenesis and tissue repair. The LLLTeffect is specific to small amounts of light and is now a well-acceptedmodality for repair of musculoskeletal injuries in athletes (21).

It is also noted that when the light is turned on, the emission patternof the light diverges rapidly from the light emitters, which may reducepower density (e.g., milliwatts per square centimeter) delivered to thetissue of vaginal muscles. On the other hand, if an uncontrolled amountof additional electrical power is added to the light emitters, the lightemitters may heat up quickly and consume disproportionate amounts ofbattery power of the rejunvenation and massage device.

The disclosed device remodels collagen within connective tissuesurrounding the vaginal lumen using one or more of thermal loading,vibration, light emittance, and duration. Thermal loading remodels theECM by causing collagen to contract, and vibration and light emittancepromote activity of the fibroblasts assisting in collagen matricesremodeling. Duration of use can be adjusted depending on the thermalload, or vice versa, to speed up or slow down the thermally-induceddenaturation.

The disclosed device is also configured to concentrate the light as itexits the power unit of the device and increase the power density beingdelivered to the tissue of vaginal muscles, which enhances thetherapeutic effects of light radiation provided by the device. Forexample, the disclosed device can include a lens assembly for each lightemitter to generate concentrated light from the light emitter throughthe lens assembly without using disproportionately more battery power,without increasing heat output from the light emitters, and withoutrisking damage to the light emitters, the device itself or the user ofthe device.

(b) Rejuvenation and Therapeutic Massage Device

FIGS. 1C-1E are examples of an embodiment of a rejuvenation andtherapeutic massage device 100. FIG. 1C provides a perspective view ofthe device 100, including a handle or end 155 of the device 100, anopposite, insertable end 175 of the device, an area or treatment window170 between ends 155 and 175, and areas 160 and 165 on either side ofthe window 170. FIG. 1D is a bottom side diagrammatic view of the device100 illustrating a user interface, light emitters, and certain internalcomponents. FIG. 1D illustrates controls or buttons 155A-D, charger 150,light emitting diodes 170A-C, portions 160 and 165 that include sensors,and vibrating device 172 (located at end 175 shown in FIG. 1C). FIG. 1Eis a side view of the device 100, including illustration of the lightemitting diodes 170A-C and showing opaque portions 180 and transparentportion 185 of the device 100.

In the embodiment shown in FIG. 1C, the device is from 2-7 inches longalong a vertical axis 105 with a diameter of from 1-3 inches along ahorizontal axis 110. In other embodiments, the shape and size of thedevice 100 may vary. During use, a portion of the device, including atleast end 175 and window 170, is placed in the vaginal lumen.

FIG. 2 illustrates components that might be found in the device 100shown in FIGS. 1C-1E, though more or fewer components can be included.According to one embodiment, the device 100 includes a vibrationcomponent 210, a safety temperature component 220, a light emittercomponent 240 having a light configuration component 242, a userinterface 250, and a power source 260. In an alternative embodiment, thedevice 200 includes a vibration component 210, a safety temperaturecomponent 220, a cooling component 230, a light emitter component 240, auser interface 250, and a power source 260. For example, in oneembodiment as shown in FIG. 1D, the vibration component 210 includes oneor more vibration devices 172 (FIG. 1D), such as motors, integratedwithin the device 100 at end 175, the safety temperature component 220includes a temperature sensor and/or an optical sensor integrated withina shell of the device and within the device at portions 160 and 165, thelight emitter component 240 includes light-emitting diodes at portion170 (which forms the treatment window for treating the tissue), and theuser interface 250 is located at a handle end of the device 100, such asend 155. The light emitter component 240, in this example, includes oneor more light emitting diodes 170B for treatment and one or more lightemitting diodes 170A and 170C as visual indicators, as shown in FIG. 1D.The handle end of the device such as at end 155 includes one or morecontrols (e.g., buttons) for turning the device on or off (e.g., 155A inFIG. 1D), turning light therapy on or off (e.g., 155C in FIG. 1D), andfor adjusting vibration (e.g., 155B and 155D in FIG. 1D). The lightemitter component 240 and user interface are further described below inconjunction with FIG. 2, and the light configuration component 242 ofthe light emitter component 240 is further described below withreference to FIGS. 7-9.

In one embodiment, the shell of the device is made of a high-durometermedical-grade silicone material, is water-clear in color, and has a veryslight deformability in structure. In another embodiment, the shell ismade of an opaque liquid crystal polymer. In yet another embodiment, theshell of the device is made of both a high-durometer medical-gradesilicone material and a transparent liquid crystal polymer. For example,as shown in a side view in FIG. 1E, the shell of the device 100 can betransparent at a location where light-emitting diodes are located in thedevice (e.g., at portion 185) and opaque at locations wherelight-emitting diodes are not located, such as portion 180, asillustrated in FIG. 1E. Portion 185 of the device thus acts as atreatment window and is the area at which light is shone from the device100 onto tissue inside the vagina to provide treatment to the tissuewhile the end 175 is inserted in the vagina.

The device can be water-proof (or water-resistant) and can be resistantto a range of lubricant chemistries. The device is thus compatible withuse of a customized medical-grade lubricant that matches the refractiveindex of the optical emitting surface to the tissue surfaces, such asthrough a water base, maximizing light transmission into the tissue andminimizing loss of light due to scattering.

The device in FIGS. 1C-1E is designed to be an at home use or as a Class1 product and does not require trained individuals for use. It is alsodesigned to be ergonomic for comfortable and convenient use. It isfurther portable, easily cleanable, can be battery-operated, and can beIPXn fluid ingress rated. It may be a handheld device, and some or allof the components can be integrated into or included on the device suchthat it can be a fully-contained consumer handheld unit.

FIGS. 1C-1E provide various examples of how the device could bedesigned. Other designs of the device can include components forstimulation of certain aspects of the female anatomy. For example, thedevice might be shaped for or include protrusions that are intended tostimulate the G-spot. The device might also include components thatextend from the device outside of the vagina intended for stimulation ofthe clitoris.

The device can have a variety of massaging features. In someembodiments, it has various vibration settings, including differentspeeds, tempos or other variations. The vibration settings can also bedesigned to maximize treatment effectiveness, including generation ofthe improved healing response caused by vibration. Certain aspects ofthe device can be designed to rotate or otherwise move to providemassage. The device can include a handle or portion that is gripped bythe hand of the user for easy insertion and manipulation, such as handleportion 155 in FIG. 1C, and some or all of the remaining portions of thedevice can be insertable into the vagina.

FIG. 2 is a block diagram of the components in the rejuvenation andtherapeutic massage device in accordance with the embodiment shown inFIG. 1C. In other embodiments, the device may include different and/oradditional components than those shown in FIG. 2 and the component mayinclude different and/or additional features than those describedherein.

The vibration component 210 applies vibration to the vaginal tissue incontact with the device. The vibration component 210 includes one ormore motors and one or more counterweights configured to operate in a5-10 Hz range, in an 8-10 Hz range, or at any frequency from 0-15 kHz(though it can also operate in other similar ranges, as desired). Forexample, one motor can operate in a frequency less than 10 Hz to providevaginal rejuvenation and one or more other motors can operate in afrequency of up to 15 kHz to induce pleasure. As another example, asingle motor provides both vaginal rejuvenation and induces pleasure.According to research, the 5-10 Hz range of vibration effects myofibrilgeneration and collagen production, enhancing tissue regeneration,neocollagenesis, and rejuvenation of vaginal tissue. In someembodiments, the vibration component 210 vibrates in whatever range isdetermined to produce effective myofibril generation and collagenproduction. The one or more motors and one or more counterweights may beflexibly coupled to the one or more portions of the inner wall of theshell of the device. In one embodiment, the one or more motors and oneor more counterweights are coupled to the one or more portions of theinner wall of the shell to maximize surface deflection or maximizeoffset of the shell to the one or more motors and one or morecounterweights. In one embodiment, the one or more motors and one ormore counterweights may be coupled inline and paired, providing phasesof vibration patterns along the vertical axis 105 of the device. Thephases of vibration patterns can be options presented to the userthrough an external user interface 250. Various vibration patterns canbe selected through the user interface 250, as further described belowin conjunction with FIG. 3. The vibration component 210 may be coupledto the device to produce vibration along the vertical axis 105 of thedevice or along the horizontal axis 110 of the device (off-axis movementfrom the vertical axis 105).

In other embodiments, the vibration component 210 includes ahigh-efficiency resonant drive mechanism, reducing power required tooperate the device. The high-efficiency resonant drive mechanismincludes a rare-earth magnetic stator surrounded by laminated armaturepieces directing magnetic lines of flux to a spring-steel rotor. Thearmature includes anti-sense coils and the anti-sense coils periodicallyand continuously imbalance the magnetic force directed by the armaturetowards the rotor, causing the rotor to deflect in the direction ofapplied force. The resonant drive mechanism is configured for resonantoperation at any desired frequency, with a preferred range of 5-10 Hz.The resonant drive mechanism can also be configured for resonantoperation in an 8-10 Hz range, or at any frequency from 0-15 kHz. Forexample, one resonant drive mechanism can operate in a frequency lessthan 10 Hz to provide vaginal rejuvenation and one or more otherresonant drive mechanism can operate in a frequency of up to 15 kHz toinduce pleasure. A primary attribute of the high-efficiency resonantdrive mechanism is that the high-efficiency resonant drive mechanismuses little drive energy for comparatively large mechanical deflections,has no moving or sliding parts which can wear, and includes simpleconstruction not requiring expensive components. In one embodiment, thehigh-efficiency resonant drive mechanism's rotor is flexibly coupled tothe outer walls of the device configured to maximize surface deflectionor vibration of key, circumscribed portions of the device, rather thanthe entire device by default. The flexible coupling maximizes energycoupling to the vaginal mucosa rather than to the hand of a user of thedevice. In another embodiment, the vibration component 210 includesadditional external motors and one or more counterweights attached to anexternal additional appendage of the device (not shown).

The safety temperature component 220 includes a thermal overloaddetection including one or more thermocouples, thermal detectors,cutoffs, optical detectors, or other suitable temperature readers ordetectors. Therefore, if the temperature of the human mucosa tissueexceeds a threshold temperature as detected by the safety temperaturecomponent 220, then the inducement generator 350, described furtherbelow in conjunction with FIG. 3, adjusts instructions sent to the lightemitter component 240 to lower or turn off LEDs and, therefore, lowertemperature through control of emission of the LEDs.

The safety temperature component 220 may also include a safety interlockincluding a heat sensor in the shell of the device that can detect humantissue (e.g., mucosa tissue) through temperature. In other embodiments,the safety interlock includes infrared sensors or other suitable sensorsable to detect human tissue in contact with the outer wall of the shellof the device. The safety interlock can prevent the device, such asthrough the light emitter component 240, from emitting light or reduceintensity of emitted light if the device is not in contact with thevaginal tissue within the vaginal lumen or equivalent.

The safety temperature component 220 can also heat the vaginal tissue incontact with the device to induce neocollagenesis. The safetytemperature component 220 is configured to operate in the range of 35°C.-80° C. to, for example, measure temperature of the shell of thedevice and/or vaginal mucosa in contact with the shell of the device upto a depth of 7 mm of the vaginal mucosa in contact with the shell ofthe device, and to allow production of heat preferably to a depth of 5mm or more on vaginal tissue in contact with the outer wall of the shellof the device, such as the vaginal mucosa. Thus, in this embodiment, thefunction of the safety temperature component 220 is performed to assistthe light emitter component 240. For example, the light emittercomponent 240 can provide a steady emission of light and thus thermalload while the safety temperature component 220 heats to keeptemperature in a temperature range that can be specified by the user orby a protocol stored in memory 360 on the device.

In the embodiment of providing thermal load, the safety temperaturecomponent 220 is configured to operate for 1 to 10 minutes, thoughlonger or shorter time periods can be used, as well. For example, insome embodiments, the safety temperature component 220 operates for aslong as a user is comfortable and shuts off or cycles at a settemperature when a threshold temperature is reached. Alternatively, thesafety temperature component 220 operates for a duration of timedictated by treatment and prior usage. For example, if treatmentincludes a protocol for use of the device three times a week, each timeusing the device for 8-10 minutes, the safety temperature component 220can operate for 8-10 minutes. If, for example, the user has already usedthe device three times in a week, then duration of the safetytemperature component 220 can decrease or an indication can be given tothe user that use of the safety temperature component 220 isunnecessary. In some embodiments, the safety temperature componentoperates in a temperature or range of temperature that is determined toproduce heat to a depth that permits collagen melting and repair. Thesafety temperature component 220 is configured to be able to treatlocalized areas of vaginal tissue as well as the entire length of thevaginal tissue along the vaginal lumen. Treating localized areas ofvaginal tissue allows for a rate of healing higher than when treatingthe entire length of the vaginal tissue due to assistance from adjacentuntreated tissue sites along the vaginal lumen.

The localized areas of vaginal tissue being treated can be selectedmanually or automatically. In the manual embodiment, the user can use asliding button with a plurality of notches corresponding to localizedareas along the vertical axis 105 of the device. In the automaticembodiment, the safety temperature component 220 selects localized areasalong the vertical axis 105 of the device based on one or moreprogrammed patterns stored in memory 360.

To complement the functions of the safety temperature component 220, insome embodiments, the device includes a cooling component 230 that coolsthe vaginal tissue in contact with the device, minimizing the user'sperception of thermal load from the device on the vaginal tissue. Thus,the cooling component 230 can help maintain a temperature of the devicein a range or below a threshold temperature. The cooling component 230includes a coaxial external sheath containing cryogenic fluid,minimizing epithelial heat load. In another embodiment, the coolingcomponent 230 includes one or more Peltier cooling devices integratedinto the inner wall of the shell of the device. In other embodiments,the cooling component 230 includes a cooling apparatus peripheral to theinner wall of the shell of the device, minimizing heat load by passiveconduction to the inner wall of the shell of the device and then to aheat-pipe assembly. Another embodiment includes a liquid coolant, suchas nontoxic propylene glycol in water, which directs excess thermalenergy from the light emitter component 240 to a heat exchanger locatedat one end of the device. The cooling component 230 is configured tocool the vaginal tissue in contact with the device to below 40° C.,though it can also be designed to cool to higher or lower temperatures,as desired. The cooling component 230 is an optional component and mayor may not be required depending on the safety temperature component220.

The light emitter component 240 emits light in a spectrum rangesufficient to prevent apoptosis and cell death, stimulate fibroblastproliferation, migration and collagen synthesis, modulate inflammatoryand anti-oxidant responses, and simulate angiogenesis and tissue repairin the vaginal tissue. The light emitter component 240 can also emitlight in a visible spectrum as a visual indicator to provide a user avisual indication in a treatment window 185 that light is being emittedin a spectrum range sufficient to prevent apoptosis and cell death,stimulate fibroblast proliferation, migration and collagen synthesis,modulate inflammatory and anti-oxidant responses, and simulateangiogenesis and tissue repair in the vaginal tissue. A visual indicatorcan also be included in a handle 155 portion of the device 100 toprovide the user an additional visual indicator that is visible duringuse of the device 100. The light emitter component 240 is configured toapply thermal load of 150 mW/cm² to a penetration depth of 3-5 mm or upto 7 mm on vaginal mucosa surrounding the device and is controlled basedon temperature readings taken by the safety temperature component 220.

In another embodiment, the light emitter component 240 can also emitlight in a range of 250-400 nm for disinfection or sterilizationpurposes. Light emitted in the range of 250-400 nm can kill bacteria andprevent infection, such as yeast infection, during use of the device.The light emitted in the range of 250-400 nm can sterilize and killbacteria in the vaginal tissue along the treatment portion of the devicesuch as portion 185 in FIG. 1E, along the device itself inserted in thevagina, or both. Thus, this light emitted can act to kill bacteria onthe tissue and or on the device. The light emitted in the range of250-400 nm can be through one or more light emitting diodes (LEDs) thatemit light in this range. For example, the device can include up to 20LEDs emitting light in this range and they can be placed in thetreatment portion of the device 185. These can be light emitters addedin addition to the light emitters shown in, for example, FIG. 1E, orsome of the light emitters in FIG. 1E could emit light in thisdisinfection range, or the light emitters can be configured to switchbetween treatment and disinfection emission ranges by control of theuser, by automated setting of the device, at certain time ranges (e.g.,disinfection for a period of time at the beginning or end of a treatmentcycle), etc.

In one embodiment, the light emitter component 240 emits light using oneor more light emitting diodes (LED). In other embodiments, the lightemitter component 240 emits light using electric lamps, incandescentlamps, other electroluminescent lamps, or lasers. The light emittercomponent 240 is configured to emit light in the 600-1000 nm range,including the red portion and the near-infrared light portion of thespectrum, resulting in of the production of low-level laser lighttherapy. The light emitter component 240 can be designed to emit lightin other ranges, as well, including less than or equal to 690 nm such asthe visible spectrum. The emitted light is capable of applying thermalload on vaginal mucosa surrounding the device and light emitted in thevisible spectrum provides an indication that the emitted light isapplying thermal load in the non-visible spectrum.

In some embodiments, the light emitter component 240 includes one ormore rings of optic segments such as light emitting diodes creating ahelicopter optic configuration allowing radial distribution of light tothe surrounding visual tissue in contact with the shell or a portion ofthe shell of the device. Thus, as one example, the light emitted fromthe device is emitted in a toroid shape or ring to illuminate a portionof the vaginal cavity rather than illuminating the entire vaginalcavity. In an alternative embodiment, the light emitted from the deviceis from a plurality of emitters coupled to the device. The plurality ofemitters can be configured as lines or rows of emitters along thevertical axis 105 of, horizontal axis 110 of, or at a diagonal acrossthe device or a portion of the device. In addition, the plurality ofemitters can be configured as rings along the horizontal axis 110, therings placed next to each other along the vertical axis 105. In someembodiments, the device includes manual or automatic click-by-clickpositionability in the vertical (axial) direction of this radial opticportion of the device, so that different axial stations within thevaginal mucosa may be treated at different points in time. In addition,it can include automated, repetitive vertical (axial) motion of thisradial optic portion of the device, so that different axial stationswithin the vaginal mucosa may be treated in rapid sequence during thesame treatment session.

In one embodiment, the light emitter component 240 includes one or morerings of a plurality of light emitting diodes that can move along thevertical axis 105 of the device. The position of the one or more ringsof the plurality of light emitting diodes can be manually selected bythe user. In the manual selection embodiment, the user can use a slidingbutton with a plurality of notches corresponding to positions along thevertical axis 105 of the device to select position of the one or morerings. In the automatic embodiment, the light emitter component 240selects positions along the vertical axis 105 of the device based on oneor more programmed patterns stored in memory 360. The one or more ringsemitting light may be configured to apply thermal load on vaginal mucosasurrounding the device or a portion of the device.

In one embodiment, the emitted light is provided by an external lightsource or box piping in light through one or more assemblies or bundlesof optical fiber cables. In another embodiment, the emitted light isprovided by a central light emitter at one end of the device operatingvia free-space optical communication and directing light along thevertical axis 105, resulting in light exiting radially out of thetransparent section peripheral to the inner wall of the shell of thedevice towards the vaginal tissue in contact with the shell of thedevice. For example, the inner wall of the shall may include a conicalreflector including angled sides configured to reflect light such thatthe light is emitted radially out of the device towards the vaginalmucosa surrounding the device at an angle. The angle, for example, isnormal to the outer shell of the device.

In one embodiment, the light emitter component 240 has a lightconfiguration component 242. The light configuration component 242 isconfigured to increase the deposited energy density into the targettissue of vaginal muscles, which enhances the therapeutic effects of thelight radiation provided by the device. The deposited energy density isa portion of the total energy generated by the LED emitters of thedevice. In one embodiment, the deposited energy density is representedby the energy density in mW/cm² units. In one embodiment, the lightconfiguration component 242 is configured to concentrate the lightemitted from the LED emitters by adding a focusing component, e.g., alens assembly, on top of each LED emitter, which increases the opticalpower density being delivered from the LED emitters to the vaginaltissue contacted by the device without providing more electrical currentto the LED emitters, without using disproportionately more batterypower, without increasing the heat output from the LED emitters andwithout risking damage to the device or to the users of the device.

FIG. 7 shows an example of a rejunvenation and massage device 700, whichprovides increased energy density to target tissue of the vaginalmuscles through the light configuration component 242 of the device. Thedevice 700 shown in FIG. 7 has 5 LED emitters, 702A, 702B, 702C, 702Dand 702E. Each of the LED emitters has a focusing component, e.g., alens assembly, associated with (e.g., positioned above or over) the LEDemitter. The focusing component can refract/bend light rays from the LEDemitters. The light emitted from each of the light emitters isconcentrated in a controlled area to form a focused beam of light, e.g.,704A, 704B, 704C, 704D and 704E, when it exits the transparent treatmentwindow 710. The focused beam of light increases the optical powerdensity being delivered to the vaginal tissue contacted by the device700.

The light configuration component 242 uses various types of a focusingcomponents to increase the optical power density being delivered to thetissue, as illustrated in FIGS. 8A-8E. FIG. 8A shows an embodiment ofthe light emitting component 240 having a light configuration component242 configured to position a lens assembly in a concave configurationfor each LED emitter on top of a transparent treatment window 810. Thelight emitting component 240 shown in FIG. 8A includes multiple LEDemitters, e.g., 808A-808D, arranged along a vertical axis inside thesurface of the treatment window 810 such that the treatment windowsurrounds the light emitting component 240. Each of the LED emitters hasone (or more) corresponding lens assembly in a concave configuration ontop of each LED emitter, e.g., corresponding lens assembly 802A on topof the LED emitter 808A. The lens assembly 802A is a transparent concavelens, which can focus light emitted from the LED emitter 808A byrefraction such that the beam of the focused light from the LED emitter802A is targeted into vaginal tissues of the user of the device. Thelens assembly on top of each LED emitter can be placed on the outsidesurface of the treatment window 810 or on the inside surface. FIG. 8Billustrates a perspective view of a lens assembly emitter in concaveconfiguration (e.g., 820A) on the outside surface of the treatmentwindow 810. In another embodiment, the concave lens can be placed on theinside surface of the treatment window 810.

In another embodiment, the light configuration component 242 includes aconvex lens on top of each LED emitter. FIG. 8C shows an embodiment ofthe light emitting component 240 having a light configuration component242 that is made up of a lens assembly in a convex configuration foreach LED emitter of the device. The light emitting component 240 shownin FIG. 8C includes multiple LED emitters, e.g., 848A-848D, arrangedalong a vertical axis inside the surface of the treatment window 810.Each of the LED emitter has a corresponding lens assembly in a convexconfiguration on top of each LED emitter, e.g., corresponding lensassembly 842A on top of the LED emitter 848A. The lens assembly 842A isa transparent convex lens which can focus light emitted from the LEDemitter 848A by refraction such that the beam of the focused light fromthe LED emitter 842A is targeted into vaginal tissues of the user of thedevice. The lens assembly 860A, 860B on top of each LED emitter can beplaced on the outside surface of the treatment window 810 as shown inFIG. 8D. In another embodiment, the convex lens for a LED emitter can bepositioned on the inside surface of the treatment window 810.

In some embodiments, the light configuration component 242 includesother focusing optical mechanisms as the focusing component instead ofusing the concave or convex lens described above. In one embodiment, aFresnel lens with concentric/annular rings of tiny ridges is used as thefocusing component of the light configuration component 242. The Fresnellens acts to refract light in the same way as a standard lens, e.g., aconcave or convex lens, but it allows for a much thinner format of theconcave/convex lens. In one embodiment, a portion or an entire topand/or bottom surface of the transparent treatment window of therejuvenating and massage device can be patterned via injection moldingto effect appropriate focusing of the light emitted from the lightemitters. In another embodiment, another optic mechanism after theinjection molding can be added to effect appropriate focusing of thelight emitted from the light emitters.

In yet another embodiment, a holographic optical element (HOE) is usedas the focusing component in the light configuration component 242. HOEworks via a process of constructive and destructive interferences toeffect appropriate focusing of the light emitted from the light emittersof the rejuvenation and massage device. The HOE can be placed anywherein the light path generated by the light emitted from the lightemitters. For example, the HOE associated with the LED emitters of thedevice can be optimized to generate appropriate focusing of the lightemitted from the light emitters in response to narrowband light waves(e.g., mono-color light waves like a laser). The HOE can be made verythin. For example, it can be as thin as a piece of paper. Similar to theFresnel lens configuration described above, a portion or an entire topand/or bottom surface of the transparent treatment window of therejuvenating and massage device can be patterned via injection moldingto effect appropriate focusing of the light emitted from the lightemitters. In another embodiment, other optic mechanisms can be addedafter the injection molding to appropriately focus the light emittedfrom the light emitters.

In some embodiments, the light configuration component 242 usesdifferent types of plastics with different refractive indices positionedover the light emitters of the device to generate appropriate focusingof the light emitted from the light emitters. In other embodiments, thematerial of the focusing components of the light configuration component242 can be non-plastic, for example, glass, liquids, vapor-depositedmetal, semiconductor material, any other suitable material or thecomposite of thereof. In one embodiment, the light configurationcomponent 242 is composed of material selected based on the wavelengthof the lighted emitted from the LED emitters. A material selected fromthe materials mentioned above, which matches the wavelength of the lightemitted from the LED emitters, can generate a high index of refractionof light such that the light emitted from the light emitters can beappropriately focused. Additionally, air or other gas like dry nitrogencan be introduced into the plastic material of the focusing component asa trapped bubble, or into the over molded silicone surface, to generatea focusing effect of the light emitted from the light emitters.

The light configuration component 242 can also be the light emittersthemselves according to one embodiment. For example, the LED emittersare micromachined or otherwise modeled prior to being integrated intothe transparent treatment area of the device in such a way as toself-focus the light as the light passes through the transparenttreatment area. FIG. 8E shows an embodiment of the light configurationcomponent 242 in a pre-lensed configuration. In this embodiment, each ofthe LED emitters, e.g., 886A-886B, includes a corresponding pre-lensedcomponent, e.g., 880A-880B. Each of the light emitters can be pre-lensedby micro-machinery or molding prior to integration into the transparenttreatment area of the device. The pre-lensed light emitters canself-focus the light themselves to target the vaginal tissues when thelight passes though the transparent treatment window 810.

It is noted that light being radiated into the human tissue tends toundergo intense scattering into a multiplicity of angles (e.g.,described by the Henyey-Greenstein scattering coefficients), whichimplies extinction of photons of the light. The scattering of lightbroadens the volume of tissue being illuminated, therefore tending tofurther reduce the instantaneous optical power density delivered to aspecific volume of tissue. The disclosed rejuvenation and massage deviceis advantageously configured to concentrate the light as it exits thepower unit of the device and increase the power density being deliveredto the tissue of vaginal muscles, which enhances the therapeutic effectsof light radiation provided by the device. The pre-focused lightgenerated by the light configuration module of the device before itenters the human tissue can offset at least a portion of the loss ofpower density on the human tissue caused by the intense scattering.

It is also noted that focusing the light from the light emitters of therejuvenation and massage device increases the energy density of thelight, but it may reduce the overall uniformity of illumination.However, the light emitters of the device can be selected to emit lightinto the tissue at a very wide angle. Therefore, the light configurationmodule 242 can be configured to adjust the emitting angle of each lightsuch that the overall uniformity of illumination on the human tissuewill not be appreciably reduced by focusing the light. Furthermore, theintense scattering of the light as described above tends to rehomogenizethe light flux within the human tissue, therefore the slightnon-uniformity caused by focusing the light is acceptable in terms ofthe enhancement of therapeutic effects of light radiation provided bythe device.

FIG. 9 shows examples of various views of a rejuvenation and massagedevice with enhanced light configuration, in accordance with anembodiment. The various views of the rejuvenation and massage deviceshown in include a top view, bottom view, front view, back view, leftside view, right side view and a perspective view. The enhanced lightconfiguration of the rejuvenation and massage device is provided by alight configuration component of the device. For example, in the topview, the device has two LED emitters each covered by a lens assembly,e.g., 902A and 902B. Similarly, in the left side view, the device hadthree LED emitters each covered by a lens assembly, e.g., 904A, 904B and904C. The light configuration component of the device is configured toincrease the deposited energy density into the target tissue of vaginalmuscles by refracting the light coming out of the LED emitters. Theincreased deposited energy density delivered to the target tissue of thevaginal muscles enhances the therapeutic effects of the light radiationprovided by the device.

Turning back to FIG. 2, the user interface 250 includes one or morebuttons or controls for powering the device, selecting a vibrationsetting, turning on or off light therapy via LEDs, and turning on or offa light indicator setting in one embodiment. In another embodiment, theuser interface 250 includes one or more buttons or controls forselecting a vibration setting, selecting a temperature setting, aduration setting, a temperature position setting, a light emittedposition setting, or any combination thereof, though some embodimentsmay include only a subset of these settings or may include additionalsettings. The buttons may include sliding buttons with notches,pushbutton switches, switches, joysticks, keypads, tactile buttons,toggle switches, rocker switches, slide switches, trackballs,microswitches, or other types of controls. In one embodiment, thebuttons or controls are at least greater than half a centimeter indiameter and of a color contrasting a color of the material of thedevice for visibility. The user interface 250 can also include a visualindicator via one or more LEDs indicating status of treatment such aswhether treatment is currently happening, treatment duration,temperature associated with treatment, or any other suitable indicatorof treatment via light therapy, vibration, or any combination thereof.For example, the visual indicator can turn on if treatment is occurringand turn off if treatment is not occurring. The visual indicator canalso be a bar and how much of the bar is lit up using LEDs can indicateduration of treatment (e.g., in minutes) or temperature of treatment(e.g., indicates whether temperature is too low, just right, or toohigh).

The power source 260, in one embodiment, includes a low voltage powerline from the device to a plug-in wall transformer. In otherembodiments, the power source 260 includes a radio frequency or othercharging apparatus built into the device and one or more batteries.Thus, the power source 260 can couple to a charging apparatus or chargerthrough a universal serial bus (USB) connection such as a Micro-B plug,UC-E6 proprietary (non-USB) plug, Mini-B plug, Standard-A receptacle,Standard-A plug, Standard-B plug, micro USB or any other suitableconnector including one or more pins necessary to charge the device. Thecharging apparatus can be configured to couple to a wall wartalternating current (AC) plug. Charger 150 in FIG. 1D is one example ofsuch a charger. Other charging systems can also be used. For example,the device might use replaceable batteries, might be wirelessly orinductively charged via a base that includes a transmitting coil thatmagnetically couples with a receiving coil in the device to inducecurrent in the receiving coil and charge the device.

In addition to the device examples provided above, a variety of otherdesigns can be used. Some embodiments include a rejuvenation and massagedevice capable of stimulating neocollagenesis and neoelastogenesisfactors, while simultaneously engaging the female sexual response inorder to maximize likelihood of repeated use of the product and thenceassure clinical benefit. Some embodiments include a rejuvenation andmassage device based on the combination of light energy to effectcollagen melting, denaturation and remodeling. Further embodimentsinclude a rejuvenation and massage device based on the combination oflight energy to effect collagen melting, denaturation and remodeling,with simultaneous vibration designed to enhance subsequent myofibrilgeneration and neocollagenesis.

Additional embodiments include a rejuvenation and massage device basedon the combination of light energy to produce an LLLT effect. The devicecan also be a rejuvenation and massage device based on the combinationof light energy to produce an LLLT effect, with simultaneous vibrationdesigned to enhance subsequent myofibril generation and neocollagenesis.Similarly, any of these device designs can be enhanced by being used inassociation with a customized medical-grade lubricant, designed to matchthe refractive index of the optical emitting surface to the tissuesurfaces in order to maximize light transmission into the tissue andminimize optical scattering loss.

Any of these designs can also be over-the-counter, Class 1 devices toeffect light-assisted vaginal rejuvenation, (as opposed to bulky,expensive, professional clinical units). Furthermore, any of thesedesigns can include a high-efficiency resonant drive mechanism based onperiodically-unbalanced permanent-magnetic fields, designed to minimizeelectrical loss while maximizing transmission of mechanical vibration toselected portions of the device structure. Thus, the device disclosed inFIGS. 1 and 2 can be modified to include components specific to any ofthese different device designs.

(c) Neocollagenesis, Neoelastogenesis, Neofibrogenesis, and PleasureInducing System and Method

FIG. 3 is an example of an embodiment of an inducement environment 300for inducing neocollagenesis, neoelastogenesis, and neofibrogenesis bythe rejuvenation and massage device illustrated in FIG. 2. Theinducement environment 300 includes an inducement system 301 and userselected settings 380 as an input to the inducement system 301. Theinducement system 301 includes software modules including a vibrationmodule 310, a temperature module 320, a light emitter module 330 havinga light configuration module 332, a duration module 340, an inducementgenerator 350, memory 360 and a processor 370. The inducement system 301receives the user selected settings 380 and, based on the user selectedsettings 380, determines range of vibration, duration of use, range ofthermal load, and amount of emitted light to ensure inducement ofneocollagenesis, neoelastogenesis, and neofibrogenesis. In alternativeembodiments, the inducement system 301 includes additional and/oralternative components than the components shown in FIG. 3.

The user selected settings 380 include a vibration setting, atemperature setting, a duration setting, a temperature position setting,a light emitted position setting, or any combination thereof. In oneembodiment, the user selected settings 380 are sent to the inducementgenerator 350 to be sent to the other modules in the inducement system301. In another embodiment, the user selected settings 380 are sentdirectly to the corresponding modules. For example, the vibrationsetting is sent to the vibration module 310, the temperature setting tothe temperature module 320, the duration setting to the duration module340, the temperature position setting to the temperature module 320, andthe light emitted position setting to the light emitter module 330.

Example vibration settings include a low setting, medium setting, and ahigh setting for a plurality of patterns including no vibration,constant vibration, pulse vibration, and wave vibration. The low, mediumand high setting increase strength of vibration for the plurality ofpatterns. Example temperature settings include various percentages ofLEDs being turned on (e.g., 0%, 25%, 50%, 75%, 100%, etc.). Exampleduration settings include how many minutes to turn the vibration and/ortemperature on such as 1 minute, 5 minutes, 10 minutes, etc. Temperatureposition settings and light emitted position settings can be optionallyprovided and include options to indicate which portion of LEDs to turnon or off and, in the embodiment where the safety temperature component220 provides heat as well, which portion of the device to provideadditional heat from the safety temperature component 220.

In the embodiment where the user selected settings 380 are sent to theinducement generator 350, the inducement generator 350 determinessettings for the corresponding modules that it sends as instructions tothe corresponding modules. For example, if the user has only selectedone setting, the inducement generator 350 determines settings for theother modules based on the one selected setting. For example, if theuser has selected a vibration setting, depending on the frequency of thesetting or a protocol for treatment, the duration can be decreased ifthe vibration frequency is higher than a threshold frequency or can beincreased if the vibration frequency is lower than the thresholdfrequency. If the user has selected a temperature setting, the durationcan be increased or decreased based on whether or not the selectedtemperature is lower than or higher than a threshold temperature,respectively. If the user has selected a duration setting, depending onthe interval of time selected by the duration setting, the temperaturesetting can be set above or below a threshold temperature based onwhether or not the interval of time selected is below or above athreshold interval of time. In one embodiment, the duration setting isnot an option available to the user and has a default run time, such as5 minutes. The vibration setting can also be set dependent on theconditions of the duration setting.

The vibration module 310 receives instructions for a vibration settingfrom the inducement generator 350, according to one embodiment. Thevibration module 310 applies a selected vibration setting, if the userselected a vibration setting, or a default vibration setting in a rangeof 5-10 Hz if no vibration setting is selected by the user. In oneembodiment, the default vibration setting includes vibration in therange of 5-10 Hz and vibration in the range of 1-15 kHz.

The temperature module 320 receives instruction for a temperaturesetting from the inducement generator 350, according to one embodiment.If the user has selected a temperature setting, the temperature module320 turns on or off one or more LEDs of the light emitter component 240.In another embodiment where the safety temperature component 220 and thecooling component 230 are included in the device, the temperature module320 also adjusts thermal load and cooling to maintain the thermal loadin the selected temperature setting. The temperature module 320maintains the thermal load applied by the light emitter component 240,the thermal load component 220, the cooling component 230, or anycombination thereof such that temperature induced by the thermal load isin a range of 35° C.-80° C. or 35° C.-41° C. as a default. Thetemperature module 320 may maintain the thermal load such that thetemperature induced is in the desired range through a local dosimetrydevice. If the received instruction includes a temperature positionsetting, the temperature module 320 sends instructions regardingposition to the light emitter component 240, the safety temperaturecomponent 220, or any combination thereof in various embodiments. Thetemperature module 320 will detect thermal overload and automaticallyshut down the device if thermal overload is detected.

The light emitter component 240 of the device provides a radiativethermal load from the light emission to penetrate and stimulate thetissue to a depth of 5 mm and, thus, the device also provides aconductive thermal load to tissue directly in contact with the device.The heat generated by the light emitter component 240 will heat thedevice and thus the shell of the device. Then, the shell of the deviceis maintained at an acceptable temperature that can be monitored by thedevice (e.g., by the safety temperature component 220). The temperatureof the shell of the device can also be high enough to warm cells in thevaginal mucosa at a depth of 3 to 5 mm with the transfer of energy fromthe radiative warming via the light emitter component 240. In oneembodiment, the safety temperature component 220 can also include atemperature sensor that monitors temperature of vaginal mucosa at adepth of up to 7 mm. The temperature sensor can monitor temperature inthe range of 60° C.-80° C., which enhances collagen rejuvenation.

The light emitter module 330 emits light in designed wavelengthsincluding red and/or near-infrared portions of the spectrum lyingbetween 600-1,000 nm as well as in the visible light spectrum. Inanother embodiment, light is emitted at wavelengths covering a spectralrange of 635-980 nm as well as in the visible light spectrum. In yetanother embodiment, light is emitted at wavelengths covering a spectralrange of 670-810 nm as well as in the visible light spectrum, and inanother embodiment, light is emitted at singular wavelengths alone, suchas 670 nm or 808 nm as well as in the visible light spectrum. In theembodiment where moveable ring-optics are used to emit light radially,the light emitter module 330 determines the position of the ring-opticsalong the vertical axis 110 of the device. In one embodiment, theposition may be determined automatically to ensure continuous exposureof the vaginal tissue in contact with the device to the emitted light.In another embodiment, the user selects the light emitted positionsetting. Then, the light emitter module 330 repositions the ring-opticsaccording to the light emitted position setting. The device can also beprogrammed via instructions in memory 360 to emit light in the visiblespectrum responsive to light in the non-visible spectrum being emitted.Therefore, the user has a visual indicator indicating emission of lightin the non-visible spectrum.

In one embodiment, the light emitter module 330 has a lightconfiguration module 332 to increase the deposited energy density intothe target tissue of vaginal muscles of a user of the device. The lightconfiguration module 332 stores executable computer programinstructions, and when executed by the processor 370, the lightconfiguration module 332 is configured to focus the light as the lightis emitted from the light emitters of the device and passes though thetreatment window of the device. In one embodiment, the lightconfiguration module 332 is associated with a light configurationcomponent, such as a focusing component, which can be located on theoutside or inside surface of the treatment window and over acorresponding light emitter.

The duration module 340 counts clock cycles while the device is in use.If the user has selected a duration setting, the duration module 340will shut down the device after the corresponding number of clock cycleshas been reached or gives an indication once the duration setting hasbeen reached. Alternatively, based on protocol for treatment and therapyas stored in the memory 360 of the device, the duration module 340 shutsdown a function of the device (e.g., vibration, light emission, etc.) ifa threshold duration as dictated by the protocol is reached.

The inducement system 301 includes a memory 360 and a processor 370. Thememory 360 includes a non-transitory computer-readable storage mediumthat stores computer-executable instructions for carrying out thefunctions attributed to the inducement system 301. The memory 360 mayadditionally store settings and default settings for the vibrationcomponent, safety temperature component, light emitter component, andduration component. The default settings can be dictated by a protocolfor treatment and therapy.

The processor 370 processes data signals and may include variouscomputing architectures including a complex instruction set computer(CISC) architecture, a reduced instruction set computer (RISC)architecture, or an architecture implementing a combination ofinstruction sets. Although only one processor is shown in FIG. 3,multiple processors may be included. The processors can include anarithmetic logic unit, a microprocessor, a general purpose computer, orsome other information appliance equipped to transmit, receive andprocess electronic data signals from the memory 360 and other devicesboth shown and not shown in the figures. In operation, the processor 370loads and executes the instructions stored in the memory 360 to carryout the inducement process described herein. An embodiment of a processperformed by the inducement system 301 is described further below inconjunction with FIG. 4.

FIG. 4 is a flowchart of one embodiment of a method 400 for vaginalrejuvenation. In other embodiments, the method may include differentand/or additional steps than those shown in FIG. 4. The functionalitydescribed in conjunction with the inducement environment 300 in FIG. 3may be provided by the inducement generator 350 in the inducement system301 or may be provided by any other suitable component, or components,in other embodiments.

In one embodiment, the method 400 is a sequential process starting withremodeling of the ECM including collagen and elastin and ending witheffecting fibrotic responses to assist in remodeling of the ECM,consequently tightening the vaginal tissue and vaginal lumen. In anotherembodiment, the method 400 remodels the ECM while simultaneouslyeffecting fibrotic responses to assist in remodeling the ECM andconsequently tightening the vaginal tissue and vaginal lumen.

An indication is received 410 by the inducement system 301 that a userhas activated the rejuvenation and massage device. The indication mayinclude notification that the device has been placed into contact withvaginal tissue from a sensor used to detect contact between the deviceand vaginal tissue. Contact of vaginal tissue with the device orpresence of vaginal tissue within a threshold distance with the devicecan also be detected using optical sensors, capacitive sensors(detecting capacitive proximity), as well as any other suitableproximity sensor. The indication could also be a notification that theuser has turned on the device or activated a particular setting.

Setting selections are received 420 (e.g., from the user or from acontroller in the device itself if the device is automatically providingsettings) to control a mechanism of the device. For example, the usermay select a vibration speed or pattern. In one embodiment, no settingselections are selected by the user and, in another embodiment, one ormore setting selections are selected. In a further embodiment, thesetting selection by the user is a default selection for the device. Thedevice itself can also determine the setting, so the setting might bereceived 420 from a component or controller in the device. Based on thesetting selections, vibration, thermal load, and duration are determined430. If the user has selected a vibration setting, the device willvibrate at the selected vibration setting. If the user has selected athermal load setting, the device will thermally load the surroundingvaginal tissue at the thermal load setting via the light emittercomponent 240, the safety temperature component 220, the coolingcomponent 230, or any combination thereof. If the user has selected aduration setting, the device will operate for the selected durationsetting. Similarly, if the instructions regarding the setting werereceived 420 within the device in an automatic setting selection mode,the device will institute the setting. In other embodiments, if nosetting selections or not all setting selections are selected by theuser, a default setting for each setting with no user setting selectionwill be determined. Instructions including the determined settings forvibration, thermal load, and duration as well as light emittance aresent 440.

FIG. 5 is a flowchart of one embodiment of a method 500 for vaginalrejuvenation performed by a user of the device. A device, such as or anembodiment of the device described in FIGS. 1C-1E with one or morecomponents as described in FIG. 2, is provided 510. The user provides510 the insertable vaginal rejuvenation device (e.g., one of the devicesdescribed above or other devices) and contacts 520 at least one contactsurface of the insertable device with mucosa tissue such as vaginaltissue. Next, the user selects 530 at least one setting selection on theuser interface of the device. In one embodiment, the selectionsavailable to the user include a vibration setting, a temperaturesetting, a duration setting, a temperature position setting, a lightemitted position setting, and any combination thereof, as described withregard to FIG. 3. To strengthen vaginal tissue and simultaneously inducepleasure, the user activates 540 the device. Alternatively, the useractivates 540 one or more settings indicating turning on vibration,light emission, or any combination thereof

FIG. 6 is a flowchart of one embodiment of a method 600 for the overallphysiological process resulting from use of a device of any of theembodiments described in FIGS. 1C-1E. Thermal load is produced 610 tothe vaginal tissue through light emission on the vaginal tissue andvibration is applied 620 to the vaginal tissue. All of these steps maybe performed or only one or two of these steps may be performed. Thethermal load is produced 610 at a sufficient rate to effect atemperature within the deep vaginal mucosa ranging from 35° C.-80° C.,and more particularly between 35° C.-41° C. and/or 60° C.-80° C., asdescribed in FIG. 3. The light is emitted in a range of 600-1000 nm aswell as in the visible light spectrum, as described in FIG. 3. Also asdescribed in FIG. 3, vibration is applied 620 at a range of 1-15 kHz andcan also be applied 620 at a range of 5-10 Hz. Producing 610 thermalload by emitting light and applying 620 vibration at a range of 5-10 Hzfor a sufficient duration of time induces 630 neocollagenesis,neofibrogenesis, or neoelastogenesis. In addition, applying 620vibration at a range of 1-15 kHz induces 630 a pleasure response in thevaginal tissue. The induced pleasure response results in a lengthening640 of the duration of time during which the thermal load is produced610 to the vaginal tissue relative to the duration of time that thermalload could be produced 610 without the induced 630 pleasure response.

(d) Summary

The foregoing description of the embodiments of the invention has beenpresented for the purpose of illustration; it is not intended to beexhaustive or to limit the invention to the precise forms disclosed.Persons skilled in the relevant art can appreciate that manymodifications and variations are possible in light of the abovedisclosure.

Any of the steps, operations, or processes described herein may beperformed or implemented with one or more hardware or software modules,alone or in combination with other devices. In one embodiment, asoftware module is implemented with a computer program product includinga computer-readable medium containing computer program code, which canbe executed by a computer processor for performing any or all of thesteps, operations, or processes described.

The apparatus described herein may be specially constructed for therequired purposes, and/or it may include a general-purpose computingdevice selectively activated or reconfigured by a computer programstored in the computer. Such a computer program may be stored in anon-transitory, tangible computer readable storage medium, or any typeof media suitable for storing electronic instructions, which may becoupled to a computer system bus. Furthermore, any computing systemsreferred to in the specification may include a single processor or maybe architectures employing multiple processor designs for increasedcomputing capability.

Finally, the language used in the specification has been principallyselected for readability and instructional purposes, and it may not havebeen selected to delineate or circumscribe the inventive subject matter.It is therefore intended that the scope of the invention be limited notby this detailed description, but rather by any claims that issue on anapplication based hereon. Accordingly, the disclosure of the embodimentsof the invention is intended to be illustrative, but not limiting, ofthe scope of the invention, which is set forth in the following claims.

The documents cited below and throughout are hereby incorporated byreference herein in their entireties for all purposes.

REFERENCES

-   1. DeLancey J O, Morgan D M, Fenner D E, Kearney R, Guire K, Miller    J M, Hussain H, Umek W, Hsu Y, Ashton-Miller J A. Comparison of    levator ani muscle defects and function in women with and without    pelvic organ prolapse. Obstetrics & Gynecology 109:295-302, 2007.-   2. Lukacz E S, Lawrence J M, Contreras R, et al. Parity, mode of    delivery, and pelvic floor disorders. Obstetrics & Gynecology 2006;    107:1253.-   3. Varma M G, Brown J S, Creasman J M, et al. Fecal incontinence in    females older than aged 40 years: who is at risk? Diseases of the    Colon & Rectum 2006; 49:841.-   4. Boreham M K, Richter H E, Kenton K S, et al. Anal incontinence in    women presenting for gynecologic care: prevalence, risk factors, and    impact upon quality of life. American Journal of Obstetrics &    Gynecology 2005; 192:1637.-   5. Fultz N H, Burgio K, Diokno A C, et al. Burden of stress urinary    incontinence for community-dwelling women. American Journal of    Obstetrics & Gynecology 2003; 189:1275.-   6. Olsen A L, Smith V J, Bergstrom J O, et al. Epidemiology of    surgically managed pelvic organ prolapse and urinary incontinence.    Obstetrics & Gynecology 1997; 89:501.-   7. D. D. Rahn, J. F. Acevedo, and R. A. Word, Effect of vaginal    distention on elastic fiber synthesis and matrix degradation in the    vaginal wall: potential role in the pathogenesis of pelvic organ    prolapse, AJP-Regu Physiol October 2008 Vol. 295 No. 4R1351-R1358.-   8. Leikina, E., et al. 2002. Proc. Natl. Acad. Sci. USA. doi    10.1073/pnas.032307099.-   9. Kei Hayashi, George Thabit III, Kathleen L. Massa, John J.    Bogdanske, A. J. Cooley, John F. Orwin and Mark D. Markel, The    Effect of Thermal Heating on the Length and Histologic Properties of    the Glenohumeral Joint Capsule, American Journal of Sports Med 1997    25: 107.-   10. Chang R. Physical Chemistry for the Chemical and Biological    Sciences. 3rd Ed. Sausalito, C A: University Science Books;    2000:470.-   11. Kushikata N, Negishi K, Tezuka Y, et al. Is topical anesthesia    useful in noninvasive skin tightening using radiofrequency?    Dermatologic Surgery 2005; 31: 526-33.-   12. Kei Hayashi, D V M, M S, Janet A. Nieckarz, B S, George Thabit    III, M D, John J. Bogdanske, B A, A. J. Cooley, D V M, and Mark D.    Markel, D V M, PhD, Effect of Nonablative Laser Energy on the Joint    Capsule: An In Vivo Rabbit Study Using a Holmium:YAG Laser, Lasers    in Surgery and Medicine 20:164-171 (1997).-   13. Tirkkonen L, et al., The effects of vibration loading on adipose    stem cell number, viability and differentiation towards bone-forming    cells, Journal of the Royal Society Interface 2011; 8(65):    1736-1747.-   14. Prè, D, et al., High-Frequency Vibration Treatment of Human Bone    Marrow Stromal Cells Increases Differentiation toward Bone Tissue,    Hindawi Publishing Corporation, Bone Marrow Research, Volume 2013,    Article ID 803450, 13 pages.-   15. C. H. Lee, H. J. Shin, I. H. Cho et al., Nanofiber alignment and    direction of mechanical strain affect the ECM production of human    ACL fibroblast, Biomaterials, Vol. 26, No. 11, pp. 1261-1270, 2005.-   16. M. Chiquet, M. Matthisson, M. Koch, M. Tannheimer, and R.    Chiquet-Ehrismann, Regulation of extracellular matrix synthesis by    mechanical stress, Biochemistry and Cell Biology, Vol. 74, No. 6,    pp. 737-744, 1996.-   17. E. Ruoslahti, Stretching is good for a cell, Science, Vol. 276,    No. 5317, pp. 1345-1346, 1997.-   18. Fagnani, F, et al., The effects of a whole-body vibration    program on muscle performance and flexibility in female athletes.    American Journal of Physical Medicine & Rehabilitation 85: 956-962,    2006.-   19. Takeuchi, R, et al., Effects of vibration and hyaluronic acid on    activation of three-dimensional cultured chondrocytes, Arthritis    Rheum. 2006 June; 54(6):1897-905.-   20. Wang, C Z, et al., Low-magnitude vertical vibration enhances    myotube formation in C2C12 myoblasts, Journal of Applied Physiology    Sep. 1, 2010 Vol. 109 No. 3 840-848.-   21. Rodrigues dos Santos, R, et al., The low-level laser therapy on    muscle injury recovery: literature review, J Health Sci Inst. 2010;    28(3):286-8.

We claim:
 1. A rejuvenation and massage device comprising: an insertablebody having at least one contact surface and being insertable into avagina, the insertable body comprising: an opaque shell forming anexternal surface of the insertable body and comprising a treatmentwindow forming a band about a portion of the insertable body; a lightemitting mechanism integrated within the insertable body, the lightemitting mechanism comprising: a set of light emitters radiallydistributed within the insertable body at the treatment window, the setof light emitters configured to emit light onto tissue within thevagina, and a light configuration component comprising a set of lensescoupled to the treatment window that are configured to focus lightemitted from the set of light emitters onto tissue within the vagina,during operation, to provide thermal adjustment to tissue within thevagina; and a vibration mechanism comprising a vibration motor retainedwithin the opaque shell of the insertable body that is configured totransmit vibration to tissue within the vagina, during operation, totone muscle.
 2. The device of claim 1, further comprising: a safetytemperature component integrated within the insertable body, the safetytemperature component comprising a thermocouple, assembly and heatingelement configured to be in thermal communication with vaginal mucosaduring operation; a cooling mechanism thermally coupled to the opaqueshell of the insertable body and operable to provide thermal adjustmentto a region of tissue within the vagina in association with discomfortreduction; a power source associated with the insertable body; acontroller configured to communicate with the insertable body andcoupled to the light emitting mechanism, safety temperature component,vibration mechanism, and power source; and a user interface coupled tothe controller and accessible by a user, the controller configured toreceive feedback from the user using the user interface wherein thedevice comprises a coordinated operation mode, wherein, in thecoordinated operation mode, the safety temperature component detects athermal condition of vaginal tissue of the user above a thresholdcondition and the controller initiates a first activation state, of thevibration mechanism and a second activation state of the coolingmechanism and the safety temperature component in response to thethermal condition.
 3. The device of claim 1, wherein wherein each of thelenses is associated with a light emitter of the light emittingmechanism and each of the lenses is configured to refract the lightemitted from the corresponding light emitter.
 4. The device of claim 3,wherein at least one of the lenses associated with the correspondinglight emitter is a concave lens assembly configured to refract the lightemitted from the corresponding light emitter.
 5. The device of claim 4,wherein the concave lens assembly associated with the correspondinglight emitter is positioned on an outside surface of the treatmentwindow, a position of the concave lens assembly on the outside surfaceof the treatment window corresponding to a position of the correspondinglight emitter within the insertable body.
 6. The device of claim 3,wherein the at least one of the lenses associated with the correspondinglight emitter is a convex lens assembly configured to refract the lightemitted from the corresponding light emitter.
 7. The device of claim 6,wherein the convex lens assembly associated with the light emitter ispositioned on an outside surface of the treatment window, a position ofthe convex lens assembly on the outside surface of the treatment windowcorresponding to a position of the light emitter within the insertablebody.
 8. The device of claim 3, wherein at least one of the lensesassociated with the corresponding light emitter is a Fresnel lens withconcentric rings of small ridges configured to refract the light emittedfrom the corresponding light emitter.
 9. The device of claim 3, whereinat least one of the lenses associated with the corresponding lightemitter is a holographic optical element configured to refract the lightemitted from the corresponding light emitter by a combination ofconstructive and destructive interference to the light emitted from thecorresponding light emitter.
 10. The device of claim 9, wherein theholographic optical element is positioned anywhere in the light path ofthe light emitted from the corresponding light emitter.
 11. The deviceof claim 9, wherein the holographic optical element is configured torefract narrowband light waves of the light emitted from thecorresponding light emitter.
 12. The device of claim 3, wherein at leastone of the lenses associated with the corresponding light emitter is thecorresponding light emitter itself in a pre-lensed configuration, thepre-lensed configuration comprising a configuration in which apre-configured optical lens is included in the corresponding lightemitter prior to the corresponding light emitter being integrated withthe treatment window of the device.
 13. The device of claim 3, whereinat least one of the lenses associated with the corresponding lightemitter is composed of one or more materials selected from a groupconsisting of different types of plastics with different refractiveindices.
 14. The device of claim 3, wherein at least one of the lensesassociated with the corresponding light emitter is composed of anon-plastic material.
 15. The device of claim 1, wherein the lightemitting mechanism is configured to operate in a near-infrared lightrange of 600-1000 nanometer and in the visible light spectrum, whereinthe near-infrared light range is sufficient to induce neocollagenesis,neofibrogenesis, or neoelastogenesis in vaginal tissue.
 16. The deviceof claim 1, wherein the light emitting mechanism is configured to use alaser operating in the deep red portion of the spectrum for low-levellaser light therapy.
 17. The device of claim 1, wherein the set of lightemitters comprise at least one light emitter configured to operate in awavelength range for providing treatment to vaginal tissue and at leastone light emitter configured to operate in a wavelength range to act asa visual indicator of operation of the device.
 18. The device of claim1, wherein the light configuration component, with the set of lightemitters, is configured to focus light onto tissue within the vagina,during operation, to provide thermal adjustment to tissue within thevagina to a first penetration depth in association with tissuerestoration; and wherein the device further comprises at least one of asafety temperature component and a cooling component thermally coupledto the opaque shell and operable to provide thermal adjustment to tissuewithin the vagina, during operation, to a second penetration depth inassociation with perceived discomfort reduction.
 19. The device of claim1, wherein the vibration motor is configured to transmit vibration,during operation, through structure of the device, including the opaqueshell and the set of lenses of the treatment window, to tissue withinthe vagina to induce a pleasure response or tone muscle.
 20. The deviceof claim 1, further comprising a proximity sensor coupled to the opaqueshell of the insertable body, wherein the proximity sensor detectscontact between vaginal tissue and the device during operation.